drugset / Trial / NCT00809939

17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor

NCT00809939

Phase 3 Unknown 800 enrolled Meir Medical Center
Non-randomizedParallel-groupOpen-labelPrevention

Summary

Preterm deliveries play a significant role in neonatal morbidity and mortality. Previous studies showed that administration of progesterone to pregnant women at high risk, decrease spontaneous preterm deliveries. The purpose of this study is to compare between two different modes of treatment with progesterone for the prevention of preterm delivery: weekly injection of 17 alfa hydroxyprogesterone caproate versus daily vaginal administration of progesterone in terms of efficacy, comfort and compliance, safety and cost of treatments.

Timeline

Start
2010-12
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator 17 alfa hydroxyprogesterone caproate Unknown 250 mg Other
Comparator Progesterone Other / unclassified 200 mg Other

Indications